7 ICH GCP informed consent fully solved graded A+ 2023/2024

7 ICH GCP informed consentinformed consent - correct answer process which is needed for ethical research in clear, easy to read, accurately reflected, language, with risks listed informed consent doc readability - correct answer consider comprehension and readability, limited med terminology, avoid informal language when is a witness needed - correct answer when presenting informed consent doc orally, required by IRB who can be witness - correct answer a person independent of trial who cannot be unfairly influenced patient information sheet - correct answer information oNLY informed consent form - correct answer used to document consent process of informed consent - correct answer discussion, review, concerns, time, signatures obtaining informed consent form - correct answer no coercion or influence ! subject must be given adequate time to ask questions and get answers form should also be signed by the person obtaining consent who can obtain consent - correct answer pi sub investigator study staff person listed with the IRB informed consent of cognitively impaired - correct answer must be signed by a legal representative (coma/dementia/retarded)